Open AccessResearch Initial validation of the Argentinean Spanish version of the PedsQL™ 4.0 Generic Core Scales in children and adolescents with chronic diseases: acceptability and com
Trang 1Open Access
Research
Initial validation of the Argentinean Spanish version of the
PedsQL™ 4.0 Generic Core Scales in children and adolescents with chronic diseases: acceptability and comprehensibility in low-income settings
Address: 1 Committee on Quality of Life, Hospital de Pediatria Prof Dr Juan P Garrahan, Pichincha 1890, Buenos Aires, (1414), Argentina,
2 Department of Research, Hospital de Pediatria Prof Dr Juan P Garrahan, Buenos Aires, Argentina, 3 Department of Neonatology, Hospital de Pediatria Prof Dr Juan P Garrahan, Buenos Aires, Argentina, 4 Department of Pulmonology, Hospital de Pediatria Prof Dr Juan P Garrahan,
Buenos Aires, Argentina, 5 Hospital Marañon, Madrid, Spain, 6 Palliative Care Team, Hospital de Pediatria Prof Dr Juan P Garrahan, Buenos Aires, Argentina, 7 Department of Pediatrics, College of Medicine, Texas A & M University, College Station, Texas, USA, 8 Department of Landscape
Architecture and Urban Planning, College of Architecture, Texas A & M University, College Station, Texas, USA, 9 Center for Outcomes and Policy Research and Department of Pediatric Oncology, Dana-Farber Cancer Institute, 44 Binney St (SM-215), Boston, 02115, MA., USA and
10 Department of Hematology/Oncology, Children's Hospital, Boston, 02115, MA, USA
Email: Mariana Roizen - mroizen@gmail.com; Susana Rodríguez - susiro@ciudad.com.ar; Gabriela Bauer - gababauer@gmail.com;
Gabriela Medin - Gabriela.medin@gmail.com; Silvina Bevilacqua - silbevi@netverk.com.ar; James W Varni - jvarni@archmail.tamu.edu;
Veronica Dussel* - veronica_dussel@dfci.harvard.edu
* Corresponding author
Abstract
Background: To validate the Argentinean Spanish version of the PedsQL™ 4.0 Generic Core
Scales in Argentinean children and adolescents with chronic conditions and to assess the impact of
socio-demographic characteristics on the instrument's comprehensibility and acceptability
Reliability, and known-groups, and convergent validity were tested
Methods: Consecutive sample of 287 children with chronic conditions and 105 healthy children,
ages 2–18, and their parents Chronically ill children were: (1) attending outpatient clinics and (2)
had one of the following diagnoses: stem cell transplant, chronic obstructive pulmonary disease,
HIV/AIDS, cancer, end stage renal disease, complex congenital cardiopathy Patients and adult
proxies completed the PedsQL™ 4.0 and an overall health status assessment Physicians were
asked to rate degree of health status impairment
Results: The PedsQL™ 4.0 was feasible (only 9 children, all 5 to 7 year-olds, could not complete
the instrument), easy to administer, completed without, or with minimal, help by most children and
parents, and required a brief administration time (average 5–6 minutes) People living below the
poverty line and/or low literacy needed more help to complete the instrument Cronbach Alpha's
internal consistency values for the total and subscale scores exceeded 0.70 for self-reports of
children over 8 years-old and parent-reports of children over 5 years of age Reliability of
proxy-reports of 2–4 year-olds was low but improved when school items were excluded Internal
consistency for 5–7 year-olds was low (α range = 0.28–0.76) Construct validity was good Child
self-report and parent proxy-report PedsQL™ 4.0 scores were moderately but significantly
Published: 7 August 2008
Health and Quality of Life Outcomes 2008, 6:59 doi:10.1186/1477-7525-6-59
Received: 27 September 2007 Accepted: 7 August 2008 This article is available from: http://www.hqlo.com/content/6/1/59
© 2008 Roizen et al; licensee BioMed Central Ltd
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Trang 2correlated (ρ = 0.39, p < 0.0001) and both significantly correlated with physician's assessment of
health impairment and with child self-reported overall health status The PedsQL™ 4.0
discriminated between healthy and chronically ill children (72.72 and 66.87, for healthy and ill
children, respectively, p = 0.01), between different chronic health conditions, and children from
lower socioeconomic status
Conclusion: Results suggest that the Argentinean Spanish PedsQL™ 4.0 is suitable for research
purposes in the public health setting for children over 8 years old and parents of children over 5
years old People with low income and low literacy need help to complete the instrument Steps
to expand the use of the Argentinean Spanish PedsQL™ 4.0 include an alternative approach to
scoring for the 2–4 olds, further understanding of how to increase reliability for the 5–7
year-olds self-report, and confirmation of other aspects of validity
Background
The shift to family/patient-centered models of care has
increased the need for patient reported outcomes Valid
and reliable health-related quality of life (HRQOL)
instru-ments are therefore expected to be in the armamentarium
of clinicians and health service researchers [1,2]
The only HRQOL instrument that has been validated in
Argentinean children is the Child's Health Questionnaire
(CHQ) in children with Juvenile Rheumatoid Arthritis
[3,4] One of the limitations of this instrument however,
is that it does not include the child's perspective for
chil-dren younger than 10 years of age
The Pediatric Quality of Life Inventory™ (PedsQL™) 4.0
Generic Core Scales is a generic HRQOL instrument for
children and adolescents, originally developed by Varni et
al in U.S English and U.S Spanish [5] It measures four
domains (physical, emotional, social, and school
func-tioning) and has age and respondent specific versions for
child self-report ages 5–18 and parent proxy-report for
ages 2–18 The PedsQL™ has shown good internal
consist-ency (α = 0.88 child, and α = 0.90 parent report)[6,7] and
has been widely used for group comparisons The
con-struct validity of PedsQL is supported by results from large
samples of children from the US [7-10]and several other
countries [11-16] where the instrument has been
trans-lated using accepted cross cultural language adaptation
methods[17] These studies have given support to the
instrument's ability to discriminate between healthy
chil-dren and those with chronic
condi-tions[7,11,12,15,16,18] and among different chronic
conditions[16,19-21] Responsiveness, i.e score change
after an intervention, has been reported for specific
condi-tions such as rheumatic diseases[22], headaches[23], and
cancer[24,25] and sensitivity, i.e ability to distinguish
among severity groups, for heart disease[7], obesity[21]
and cancer[24,25] has also been described In addition,
the PedsQL is able to discriminate among children from
lower socioeconomic strata[8,11] and predict variation in
health care utilization and costs[26,27]
The aim of this study was to validate the Argentinean Spanish version of the PedsQL™ 4.0 in children and ado-lescents with chronic conditions Given that families who receive care at public health settings in Argentina come from low income sectors, usually have low literacy skills, and are not used to self-reporting their health status, we specially focused on the impact of socio-demographic characteristics on overall comprehensibility and accepta-bility
Methods
Subjects
Patients were considered eligible if they were: (1) 2–18 years old, (2) receiving outpatient care at Hospital Nacional de Pediatria Juan P Garrahan, and (3) had one
of the following conditions: Allogeneic Hematopoietic Stem Cell Transplantation (SCT), Chronic Obstructive Pulmonary Disease requiring domiciliary oxygen (COPD), Human Immunodeficiency Virus infection or Acquired Immune Deficiency Syndrome (HIV/AIDS), Cancer, End Stage Renal Disease (ESRD) requiring dialysis
or transplant, or a Complex Congenital Cardiopathy (CCC) Patients were excluded if they had not been clini-cally stable in the last month (i.e., deterioration and/or acute complication related or not to their preexisting con-dition), had comorbidities, or were not cognitively able to complete the questionnaire Data were collected from July
2004 to June 2005
An additional convenience sample of healthy children and adolescents was gathered to assess comprehensibility and test discriminant validity Eligibility criteria for this sample were: (1) 2–18 years old, (2.a) attending the
"Healthy Children Outpatient Clinic" at one of the three pediatric hospitals in the city or (2.b) students at one ele-mentary school in the outskirts of Buenos Aires These recruitment sources were selected because the socio-demographic characteristics of children were similar to those of the chronically ill children cared for at Hospital Garrahan The study was approved by Hospital Garra-han's IRB Parents or legal guardians granted written
Trang 3per-mission and children 10 years old and above were asked
for assent
Instruments
The PedsQL™ 4.0 Generic Core Scales
The 23-item PedsQL™ 4.0 Generic Core Scales encompass:
1) Physical Functioning (8 items), 2) Emotional
Func-tioning (5 items), 3) Social FuncFunc-tioning (5 items), and 4)
School Functioning (5 items), and were developed
through focus groups, cognitive interviews, pre-testing,
and field testing measurement development
proto-cols[5,6] The instrument takes approximately 5 minutes
to complete[5,6] The PedsQL™ Scales are comprised of
parallel child self-report and parent proxy-report formats
Child self-report includes ages 5–7, 8–12, and 13–18
years Parent proxy-report includes ages 2–4 (toddler), 5–
7 (young child), 8–12 (child), and 13–18 (adolescent),
and assesses parent's perceptions of their child's HRQOL
The items for each of the forms are essentially identical,
differing in developmentally appropriate language, or first
or third person tense The instructions ask how much of a
problem each item has been during the past one month
A 5-point Likert response scale is utilized across child
self-report for ages 8–18 and parent proxy-self-report (0 = never a
problem; 1 = almost never a problem; 2 = sometimes a
problem; 3 = often a problem; 4 = almost always a
prob-lem) To further increase the ease of use for the young
child self-report (ages 5–7), the response scale is reworded
and simplified to a 3-point scale (0 = not at all a problem;
2 = sometimes a problem; 4 = a lot of a problem), with
each response choice anchored to a happy to sad faces
scale[28,29]
Items are reverse-scored and linearly transformed to a 0–
100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that
higher scores indicate better HRQOL Scale Scores are
computed as the sum of the items divided by the number
of items answered (this accounts for missing data) If
more than 50% of the items in the scale are missing, the
Scale Score is not computed This accounts for the
differ-ences in sample sizes for scales reported in the Tables
Although there are other strategies for imputing missing
values, this computation is consistent with the previous
PedsQL™ peer-reviewed publications, as well as other
well-established HRQOL measures [6,30,31] The
Physi-cal Health Summary Score (8 items) is the same as the
Physical Functioning Scale To create the Psychosocial
Health Summary Score (15 items), the mean is computed
as the sum of the items divided by the number of items
answered in the Emotional, Social, and School
Function-ing Scales
The adaptation of the PedsQL™ 4.0 Generic Core Scales
into Argentinean Spanish was conducted following
inter-nationally accepted guidelines for cross-cultural
adapta-tion of patient reported outcome instruments[17,32,33] The forward translation into Spanish of all the PedsQL™ corresponding versions was conducted by two of the authors (VD, GM), a paediatrician and a child psycholo-gist who are fluent in English This first draft was reviewed
by a multidisciplinary team that included the two authors,
a child oncologist, and a health services researcher/clini-cian After extensive discussion we ended up with a recon-ciled first Argentinean Spanish PedsQL™ version The back translation was done by a native English speaker fluent in Spanish not familiar with the instrument Some items were slightly modified to ensure semantic and conceptual equivalence of the second Argentinean Spanish PedsQL™ version Cognitive debriefing interviews were carried out
in two waves, first with 15 children and their parents This pretest prompted changes that essentially involved spell-ing out both the main question and answer options more thoroughly (e.g "problems with running" instead of
"running" and "never was a problem" instead of "never")
to increase comprehensibility The second wave of cogni-tive interviews was carried out in 30 children and parents and confirmed that the final Argentinean Spanish Ped-sQL™ was understandable and conceptually equivalent to the original instrument All changes and revisions were reviewed and accepted by JV
Overall Health Status Ratings
Overall health status ratings were developed for this study (see Figure 1) Physicians were prompted to assess the child's degree of health impairment due to their disease over the past month using a 0–10 visual analogue scale (VAS) where 0 was "no impairment at all" and 10 "maxi-mum impairment" Children 5 years old and above and their proxies were asked to independently score how they considered the child was feeling over the last month Chil-dren 8 years old and above and adults used a 0–10 VAS, where 0 was "very bad" and 10 "very well", whereas 5 to 7 year-olds used a three-point faces scale (very bad, more or less, very well) similar to the faces scale used in the corre-sponding PedsQL™ version
Cognitive Debriefing/Feasibility
Children and proxy's impressions about the Argentinean Spanish version of PedsQL™, including difficulty with for-mat and understanding, easiness, and comprehensibility were asked with a semi-structured cognitive interview
Clinical and Socio-demographic variables
Clinical information such as diagnosis, disease severity, and duration of disease was abstracted from the patients' medical records and, when not available, was collected from the patients' primary physicians
Age, gender, education level of the child and adult proxy, and socioeconomic status were collected from adult
Trang 4prox-ies Socioeconomic status variables included health
insur-ance (union health insurinsur-ance/private insurinsur-ance/disability
allowances/uninsured), and poverty level, which was
dichotomized as above or below the poverty line
accord-ing to the ratio income/basic family livaccord-ing costs[34]
Design
This is a cross-sectional descriptive study One interviewer
(MR, not related to patient care) administered the
Ped-sQL™ 4.0 and the validation questionnaire to all enrolled families
Construct validity was assessed by testing the following hypothesis: (1) PedsQL™ 4.0 scores would correlate nega-tively with physician's assessed impairment of health sta-tus; (2) PedsQL™ 4.0 scores would correlate positively with self/proxy-reported overall health status; (3) Child self-reported and parent proxy-reported PedsQL™ 4.0
Visual analogue scales used to measure overall health status
Figure 1
Visual analogue scales used to measure overall health status Visual analogue scales (VAS) used to measure overall
health status Upper panel shows the VAS presented to physician's to assess degree of heath impairment in the past month Middle panel shows VAS presented to older children and parents to assess overall health status in the past month Lower panel shows faces scale used to assess self-reported overall health status in children aged 5 to 7 years old
x Physician’s assessment of health impairment (VASphys):
In the past month, how much do you believe (name of the patient)’s disease impaired
his/her health status?
0 — — — — — — — — — — 10 (nada) (mucho)
(not at all) (very much)
x Overall health status scales for children aged 8-18 (VASc) and parents (VASp):
Think how you/your child were/was feeling this past month…
¿How would you/your child score if 0 is feeling very poorly and 10 is to feel very
well?
0 — — — — — — — — — — 10 ( muy mal) (muy bien)
x Overall health status scale for 5 to 7 year-olds:
¿How do you think you are?
Muy mal Mas o menos Muy bien
/.-(very bad) (more or less) (very well)
Trang 5scores would correlate significantly in the medium effect
size range In addition, we used the known-groups
approach to test discriminant validity by comparing
Ped-sQL™ 4.0 scores of healthy children with those of children
with chronic health conditions, as well as scores across
different chronic conditions groups It was anticipated
that children with chronic health conditions would report
significantly lower PedsQL™ scores overall in comparison
to healthy children[19]
Procedures
For the field test, outpatient clinic rosters were reviewed
with primary physicians who identified subjects that met
inclusion criteria Families were then approached in the
clinic before seeing their doctor and invited to enroll in
the study After enrolling, children and proxies were asked
to independently complete the PedsQL™ followed by the
cognitive debriefing interview Overall health status
assessment was carried out after the PedsQL™
administra-tion to avoid cuing Proxies provided socio-demographic
information at the end Primary physicians were asked to
report the child's overall health impairment after they saw
the patient
The following variables were collected by the interviewer
as patients completed the instruments: (1) mode of
administration (self-administered, required
interviewer-administration), (2) version used (as per PedsQL™
guide-lines when a patient did not understand their age-specific
version they were offered the next younger age version),
(3) completion time, (4) need for help (classified in 3
cat-egories: no help, minimal help: < 4 times, and significant
help: ≥ 4 times during questionnaire administration), and
(5) missing items
Statistical Analysis
To assess the appropriateness of the PedsQL™
administra-tion in the Argentinean public health setting we set an a
priori condition indicating that at least 80% of the
ques-tionnaires should be answered based on an empirical
con-sideration that if more than 20% of the targeted sample
was not able to complete the questionnaire, the tool
would not serve the purpose of generating valid,
repre-sentative data[35] Questionnaires were considered
unan-swered if they took more than 30 minutes to complete
(this was considered a reasonable time for research
pur-poses given that not everyone was expected to take so
long) or if more than 50% of items were not understood
despite interviewer's assistance (following the author's
guidelines[36] of not scoring questionnaires with more
than 50% of missing items[31]) In addition, the
associa-tion between comprehensibility and sociodemographic
covariates was analyzed using T-test for independent
sam-ples and Chi Square or Fisher's exact test as appropriate A
p-value < 0.05 was considered significant
Descriptive statistics of the items, average scores, as well as ceiling and floor effects are reported Ceiling and floor effects were considered present if > 15% of respondents used the extreme values[37] Scores were stratified by respondent, age group, and type of chronic condition Scale reliability was evaluated using Cronbach's coeffi-cient alpha Construct validity was tested using Pearson's correlation coefficient Discriminant validity was evalu-ated by testing differences among chronic and healthy children scores, disease subgroups, gender, and SES using t-test or ANOVA for binary and categorical variables respectively Data analysis was conducted with SPSS 10.0 for Windows
Results
Among 296 eligible families of children with chronic con-ditions 287 (96%) enrolled Figure 2 presents the study flowchart and diagnosis of the enrolled families In Table
1 their clinical and socio-demographic characteristics are presented
The distribution of socio-demographic characteristics across the different age groups was homogenous, with slight predominance of males in all of them Twenty-five percent of children were below the appropriate school level for their age, and 6% were not attending school; 11%
of adult respondents had not completed elementary school and 3.2 % were functional illiterates Most sur-veyed families lived below the poverty line (66%) and 54% had no health insurance
Out of 107 eligible families of healthy children, 105 (98%) enrolled Healthy children were comparable to those with chronic conditions, except for gender and soci-oeconomic status Healthy children were more likely to be females (55% vs 42%, p = 0.023), have no medical insur-ance (74% vs 54%, p = 0.001), and less likely to live below the poverty line (54% vs 66%, p = 0.046)
Feasibility
In Table 2, we present feasibility of administering the Argentinean Spanish version of the PedsQL™ 4.0 Overall, the instrument was well understood Median time to com-pletion was 6 minutes for children (range 2–28') and 5 minutes for adults (range 1–16') In 54% of the cases the age-appropriate questionnaire was completed without help and in 27.5% with minimal help The need for help decreased with age Among the 217 children with chronic conditions surveyed, 9 (4.1%), all aged 5 to 7 years, were not able to understand and complete the questionnaire and 7 (3.5%), all aged 8 to 12 years, needed to use the young child version for 5–7 year olds An additional 7%, mostly 8–12 year-olds, required the PedsQL™ to be administered by the interviewer No health condition was associated with not being able to answer No adult
Trang 6ques-tionnaire was unanswered Main difficulty for adults was
with format, 12.5% forgot to complete an item or more
and needed to be prompted by the interviewer in order to
complete it adequately
Poverty and a low education level were significantly
asso-ciated with requiring more help to complete the PedsQL™
4.0 for both children and parents (Table 3) When both
poverty and low education level were present, 30% of
children and 19% of parents required significant help
whereas only 15% of children and 4% of parents required
significant help if they were not in this category (p = 0.049
for children and 0.001 for parents) All but one of the
chil-dren who could not complete the questionnaire lived
below the poverty line
There were few missing items Children only left 2.4%
(115/4784) items unanswered whereas adults left 4.3%
(218/6461) Five items from the school dimension were
responsible for 78% of children's and 90% of adult's
miss-ing items, and corresponded to children that were not
going to school
Almost all children (95%) and parents (96%) considered
the questions relevant, a large proportion found them
easy to answer (81% of children and 91% of parents), and most said the paper format was friendly (91% of children and 98% of parents)
Scores Distribution
In Table 4, average summary and scales scores, standard deviations and range, as well as ceiling and floor effects are presented Children and adults used the complete range of response options for all 23 items with a slight deviation towards the uppermost end Ceiling and floor effects were negligible for all dimensions but the social domain, where a moderate ceiling effect (20.2%) was observed in proxy respondents
Older children had significantly higher scores than younger children (Table 5), except for the emotional dimension In contrast, parent proxy-report scores for the 2–4 year-olds were significantly higher than proxy-report scores of older children
Reliability
Cronbach's alpha coefficients for the summary and scale scores for all children with chronic conditions are pre-sented in Table 4 Table 5 presents results by age group The internal consistency of the total scores, and the
phys-Flowchart and Patient Diagnosis for the Argentinean Spanish Validation of PedsQL™ 4.0 in children with chronic conditions
Figure 2
Flowchart and Patient Diagnosis for the Argentinean Spanish Validation of PedsQL™ 4.0 in children with chronic conditions 1Hematopoietic Stem Cell Transplant 2Chronic Obstructive Pulmonary Disease 3Human Immunodefi-ciency Virus infection or Acquired Immune DefiImmunodefi-ciency Syndrome 4End Stage Renal Disease 5Complex Congenital Cardiopa-thies
Trang 7ical and psychosocial subscale scores exceeded the 0.70
minimum usually accepted for group comparison for all
age groups except for the 2–4 year-olds proxy-report, and
the physical functioning and psychosocial subscales of the
5–7 year-olds self-report (α = 0.57 and α = 0.65
respec-tively) In the 2–4 year-old group, educational items were
missing for 51 (72.9%) patients When these three items
were excluded, internal consistency increased markedly
(total α = 0.83 and psychosocial α = 0.76)) Emotional,
social, and school subscales had overall lower reliability
although the proxy-reports of the 5–7, 8–12, and 13–18
year-olds, and the 13–18 year-olds self-report were close
or superior to the 0.70 mark (except for the emotional
subscale of the 8–12 year-old proxy-reports with an α =
0.62) and below 0.65 for the other groups (the 5–7
year-old reports being the lowest) Among child
self-reports, internal consistency increased with age
Construct Validity
As hypothesized, there was a significant and negative
cor-relation between the primary physician's assessment of
health impairment status (VASphys) and both self-report
and proxy total PedsQL™ 4.0 scores (Table 6) Correlation between total PedsQL™ scores and overall self-reported/ proxy health status evaluation was significant and positive
in both children and adults Total self-report and proxy-report scores were also significantly correlated Of note, self-report global scores were significantly lower than proxy-report global scores All correlations were in the moderate range (<> 0.20–0.50)
Discriminant Validity
As expected, child self-report and parent proxy-report total, physical, and psychosocial scores for healthy chil-dren were on average significantly higher than those of children with chronic conditions (Table 7) except for the emotional and school self-report subscales PedsQL™ 4.0 total scores also varied significantly across health condi-tions for both self-reports and proxy-reports (Table 7) Patients with COPD, ESRD, or cancer reported the lowest scores
Children living below the poverty line were more likely to have lower total PedsQL™ scores (65.38 vs 70.29
respec-Table 1: Characteristics of children with chronic health conditions Argentinean Spanish Validation of the PedsQL™ 4.0 Generic Core Scales.
Age Group 2–4
years old
n = 70
5–7 years old
n = 62
8–12 years old
n = 90
13–18 years old
n = 65
TOTAL
N = 287
Patient gender
Female 41.5% 39% 42% 46% 42% Male 58.5% 61% 58% 54% 58% Proxy respondent
Mother 80% 76% 70% 61.5% 72% Father 14% 14.5% 20% 9.5% 15% Other 6% 9.5% 10% 29% 13%
Chronic condition
SCT 1 (n = 40) 7% 8% 16% 25% 14% COPD 2 (n = 53) 24% 29% 14% 8% 18% HIV/AIDS 3 (n = 57) 19% 24% 19% 18% 20% Cancer (n = 56) 21% 20% 18% 20% 20% ESRD 4 (n = 31) 3% 3% 18% 17% 11% CCC 5 (n = 50) 26% 16% 15% 12% 17% Time since diagnosis in months, median (range) 28 (1–60) 63 (1–84) 89 (1–148) 95 (2–204) 48 (1–204)
Socio-Demographics
Education
Child below appropriate for age - 11% 29% 34% 25% Proxy did not complete elementary school 3% 11% 4.5% 15.5% 11% Below the poverty line 6 67% 71% 65% 60% 66%
No health Insurance 67% 61% 44.5% 46% 54%
1 Stem Cell Transplant 2 Chronic Obstructive Pulmonary Disease 3 Human Immunodeficiency Virus infection or Acquired Immune Deficiency Syndrome 4 End Stage Renal Disease 5 Complex Congenital Cardiopathies 6 Poverty line is calculated according to total income, and number and age
of people in the household, as per National Institute of Statistics and Census (INDEC) guidelines.
Trang 8tively, p = 0.035) than their counterparts These were
mainly due to significantly lower emotional and school
functioning scores No statistically significant differences
were found between PedsQL™ scores and gender
Comparison with other cross-cultural adaptations
Table 8 presents how results from our study compare to
the original validation study and other published
cross-cultural validations of PedsQL™ For most cross-cross-cultural
validation studies population characteristics differed from
ours Target population was commonly restricted to
school children, and thus children were older and
health-ier In addition, because of country characteristics,
socioe-conomic status tended to be higher compared to the
Argentinean families we recruited Our scores were overall
lower than most of the other validation studies, including those that included similar age ranges and conditions Reliability was reported in different ways across these studies, but the lower bound of internal consistencies found by our study was lower than the ones reported for most of the other validation studies Types of validity tested and findings were similar to those reported by the other cross-cultural adaptations
Discussion
Our study results provide initial evidence towards the reli-ability and validity of the Argentinean Spanish version of the PedsQL™ 4.0 Generic Core Scales in the public health research setting The Argentinean Spanish version of the PedsQL™ 4.0 has good feasibility It was easy to
adminis-Table 2: PedsQL 4.0 Argentinean Spanish Administration: Difficulties, help, and time to completion in children with chronic
conditions
Children Adults 5–7 yo
n = 62 1
8–12 yo
n = 90
13–18 yo
n = 65
TOTAL
n = 217
Total
n = 287 Time to completion, minutes
Median (range) 5'(3–20) 7'(2–28) 5'(2–12) 6'(2–28) 5'(1–16)
Required Help 1
No 42% 46.5% 77% 54.5% 69% Minimal 32% 29% 21.5% 27.5% 26% Significant 11.5% 24.5% 1.5% 14% 5%
Form of Administration
Adequate 100% 78% 97% 89,5% 95,5% Administered by interviewer N/A 2 14.5% 3% 7% 4,5%
Previous version N/A 3 7.5% 0% 3.5% N/A 4
Difficulties with the format
Forgot N/A 2 10% 3% 5.5% 12.5% Wrote over other item N/A 2 11% 4.5% 6.5% 4%
1 Minimal help: < 4 times, Significant: ≥ 4 times during questionnaire administration.
2 N/A: not applicable, always administered by interviewer
3 N/A: not applicable, No existence of previous versions
Table 3: PedsQL 4.0 Argentinean Spanish Administration: Socioeconomic status, education and requirement of help to complete PedsQL in children with chronic conditions and their parents
Required Help 1
Living below poverty line
Children 69 (47%) 41 (29%) 32 (23%) 0.025 Parents 122 (65%) 53(28%) 14 (7%) 0.026
Low education
Children (lower than expected) 22 (40%) 16 (29%) 17 (31%) 0.008 Parents (incomplete elementary school) 17 (53%) 10 (31%) 5 (16%) 0.030
Low income and low education
Children 18 (42%) 12 (28%) 13 (30%) 0.049 Parents 12 (44%) 10 (37%) 5 (19%) 0.001
1 Minimal help: < 4 times, Significant: ≥ 4 times during questionnaire administration or could not complete questionnaire 2 Chi-square test
Trang 9ter, completed without or with minimum help by most
children and parents, required a short administration
time (not more than 5–6 minutes on average), and only
4.1% of children (all 5–7 year-olds) could not complete
the instrument However, our results suggest that some
sort of help, albeit small, is needed for many, especially
for children and parents from lower socioeconomic strata
and low literacy levels Internal consistency approached
or exceeded that required for group comparisons for
chil-dren over 8 years old and parents of chilchil-dren over 5 years
old The Argentinean Spanish version of the PedsQL™ 4.0
showed good construct and discriminant validity
proper-ties in this low-income setting, making this instrument
suitable for research use In order to expand the use of the
PedsQL™ 4.0 in Argentinean children, an alternative
approach to scoring for the 2–4 year-olds should be
con-sidered along with further understanding of how to
increase reliability for the 5–7 year-old self-report and
assessment of other instrument characteristics such as
responsiveness and sensitivity to change
Our initial concern that socioeconomic status and literacy
may influence people's ability to use PedsQL™ 4.0 seems
to be supported by our data, although to a lesser extent
than was expected As a matter of fact, all children that
could not complete PedsQL™ 4.0 lived below the poverty
line and both children and parents who were poor and
had low literacy levels were more likely to require help
with the instrument Nevertheless, the 14.5% of 5–7
year-olds who could not complete PedsQL™ was lower than the 38% observed in the German validation of the Ped-sQL™[38], and was also within our a priori requirement of
< 20% unanswered questionnaires Importantly, all the parents were able to complete the questionnaire, albeit with assistance, even those that had not completed ele-mentary school or were functional illiterates The main implications of these findings are that in order to use Ped-sQL™ in our public health setting, availability of trained interviewers during questionnaire administration needs
to be assured, especially for children and parents who are poor and have low literacy levels In addition, carefully thought training guidelines for children and parents should be developed and tested
The Argentinean Spanish PedsQL™ version had lower reli-ability compared to other validation studies[11-13,15,16,18,20,38,39] Given the low prevalence of school attendance among the 2–4 year olds with chronic conditions, this version of the Argentinean Spanish Ped-sQL™ may work better if school items are not taken into consideration for scoring purposes in this group In addi-tion, although Cronbach alpha represents the lower bound of the reliability of a measurement instrument, and is a conservative estimate of actual reliability[40], scales that did not approach or meet the 0.70 standard should be used only for descriptive analyses Self-report scores of 5–7 year-olds presented the lowest internal con-sistency values Of note, these children had the most
dif-Table 4: Scale Descriptives for Argentinean Spanish version of the PedsQL 4.0 Generic Core Scales Child Self-Report and Proxy-Report
(%)
Ceiling Effect 2
(%)
Self-Report
Total 66.87 ± 16.74 26–99 0 0 177 0.86 Physical 67.76 ± 19.6 0–100 0.5 4.8 196 0.69 Psychosocial 66.36 ± 17.49 27–100 0 0.5 186 0.80 Emotional 65 ± 21.31 0–100 0.5 5.3 208 0.59 Social 69.1 ± 21.67 10–100 0 11.1 203 0.59 School 65.6 ± 21.3 10–100 0 5.2 189 0.62
Proxy-Report
Total 73.36 ± 16.09 14–100 0 1.7 183 0.87 Physical 74.67 ± 20.06 4–100 0 10.1 272 0.78 Psychosocial 72.41 ± 16.45 18–100 0 2.4 189 0.81 Emotional 69.16 ± 19.6 5–100 0 6.3 285 0.66 Social 77.78 ± 20.73 5–100 0 20.2 283 0.71 School 68.74 ± 24 5–100 0 1.7 192 0.68
1 Higher mean values indicate better HRQOL (range 0–100).
2 Floor and ceiling effects are considered present if > 15% of extreme values were used
3 Cronbach α Coefficient.
Trang 10ficulty with completing PedsQL™, which may be
indicating that results of the Argentinean Spanish
Ped-sQL™ version for this age group may not be as reliable as
for the older groups Although these results are somewhat
comparable to the German validation[38], other studies
in this age group [9,20] have showed higher alpha
coeffi-cients and less problem with instrument completion
HRQOL measurement in young children is still
challeng-ing and our results warrant further research includchalleng-ing
larger samples[41,42]
Construct validity was assessed in a similar fashion to
other validation studies[6,12-14,16,20,38,43] and
sup-ported by our data The self-resup-ported health status VAS
scales had not been used before in our setting, but there is
substantial evidence that VAS scales are reliable and valid
tools to assess general health status [44] Of note, all
cor-relations were in the moderate range which indicates that
although statistically significant they are not highly pre-dictive of one another
Our results also indicate that the Argentinean Spanish ver-sion of the PedsQL™ 4.0 has good discriminant validity The Argentinean Spanish version of the PedsQL™ was able
to distinguish between healthy and chronically ill chil-dren and between those with different chronic health con-ditions, as previously reported for the U.S English version[19] As was found in previous studies[8,11], the Argentinean Spanish PedsQL™ was also able to discrimi-nate between SES levels Interestingly, the Total Scale Score and scale scores of the Argentinean Spanish version
of the PedsQL™ were consistently lower than those reported in the original publication[6] and almost all published cross-cultural adaptations[11-16,18,38,39,45] for both the chronically ill and healthy samples Our results could be reflecting the socioeconomic
characteris-Table 5: PedsQL 4.0 Argentinean Spanish Scores and internal consistency by age group (Analysis of Variance – ANOVA)
Total Score (SD)
α1 N Mean
Total Score (SD)
α1 N Mean
Total Score (SD)
Total Score (SD)
α1 Differences 2
Self-Report
Total N/A N/A 3 N/A 43 60.03
(15.86)
0.76 76 66.75
(16.8)
0.86 58 72.6
(15.41) 0.89 Physical N/A N/A N/A 49 62.20
(20.40)
0.57 85 66.36
(20.24)
0.73 72 74.24
(16.24)
0.71 13–18yo > 5–7yo***
13–18yo > 8–12yo* Psychosocial N/A N/A N/A 45 58.81
(16.13)
0.65 80 66.98
(17.34)
0.81 61 71.67
(16.83)
0.86 8–12yo > 5–7yo**
13–18yo > 5–7yo*** Emotional N/A N/A N/A 53 62.07
(23.56)
0.45 90 63.47
(21.03)
0.62 65 69.54
(19.3) 0.72 NS Social N/A N/A N/A 49 57.23
(20.64)
0.28 89 70.05
(20.68)
0.59 65 77.61
(19.64) 0.73 8–12,13–18yo > 5–7yo*** School N/A N/A N/A 47 56.80
(20.86)
0.44 81 68.47
(21.69)
0.65 61 68.47
(19.53)
0.69 8–12yo > 5–7yo***
13–18yo > 5–7yo**
Proxy-Report
Total 66 80.15
(13.19)
0.62 4 50 73.88
(16.26)
0.89 80 69
(21.24)
0.84 53 71.25
(17.18) 0.89 2–4yo > 8–12,13–18yo*** Physical 66 82.34
(14.94)
0.65 58 74.78
(21.3)
0.86 87 70.12
(21.24)
0.77 61 72.59
(20)
0.78 2–4yo > 8–12***
2–4yo > 13–18yo* Psychosocial 69 78.41
(14.29)
0.30 5 53 73.33
(16.5)
0.83 81 68.4
(15.62)
0.77 55 70.62
(18.01)
0.84 2–4yo > 8–12***
2–4yo > 13–18yo* Emotional 70 75.46
(15.4)
0.54 62 69.68
(19.97)
0.73 90 66.05
(19.04)
0.62 63 66.17
(22.58)
0.75 2–4yo >
8–12,13–18yo* Social 69 83.86
(17.65)
0.65 61 77.38
(20.10)
0.65 90 73.67
(21.95)
0.72 63 77.30
(21.54) 0.79 2–4yo > 8–12yo* School 20 73.68
(13.96)
0.47 54 71.76
(22.06)
0.74 81 65.72
(22.4)
0.65 57 68.65
(20.55) 0.64 NS
1 Cronbach α Coefficient 2 p values based on analysis of variance (ANOVA) comparing the mean scores across age groups *p < 05 **p < 0.01 ***p
< 005 with Bonferroni correction for the number of comparisons, p < 005 values should be considered statistically significant NS: non significant,
p > 0.05 3 N/A: not applicable 4 If school items are excluded, α = 0.83 5 If school items are excluded, α = 0.76.